Foldable intraocular lenses with highly flexible optic and rigid fixation members

Abstract

An intraocular lens having an ultrathin and highly pliable optic and relatively more rigid fixation members extending outward therefrom. The optic desirably includes a flange to which a common arm of a pair of joined fixation members attaches. The fixation members extend on opposite sides of the optic in U-shaped flex portions spanning a distance larger than the diameter of the optic. The fixation members may be flexed inward so as to overlap within the diameter of the optic and define an insertion profile of less than about 5 mm. For anterior implantation, four relatively evenly circumferentially spaced pods are provided by the pair of fixation members. The optic center desirably has a thickness of less than about 0.5 mm for meniscus type optics, and may be made of silicone, hydrophilic acrylic, or hydrophobic acrylic. The fixation members have a thickness of about 0.25 mm and are desirably made of poly methyl methacrylate (PMMA) or polyether sulfone. The arm common to the fixation members extends radially inward to the flange and is attached thereto by heat staking, laser welding, or ultrasonic welding, preferably using a separate coupling member. The coupling member may be made of the same material as the arm and desirably has a projection that fits through an aperture in the flange and directly contacts a portion of the arm for a more secure bond.

What is claimed is:  
     
         1 . A foldable intraocular lens for implantation in the eye, the intraocular lens comprising: 
 an optic centered on an optical axis and made of a highly pliable material, the optic having a generally circular periphery and an integral flange extending radially outward therefrom;    a cantilevered arm extending radially outward from the periphery of the optic made of a material that is flexible but more rigid than the material of the optic, the arm being attached to the optic; and    a pair of fixation members integral with the cantilevered arm for supporting the optic centered on the optical axis of the eye, each fixation member having a proximal end at the outer end of the cantilevered arm, a distal end, and a flex portion intermediate the proximal and distal ends, wherein the flex portions extend generally away from one another adjacent to their respective proximal ends on diametrically-opposed sides of the optic.    
     
     
         2 . The intraocular lens of  claim 1 , wherein the material of the optic is selected from the group consisting of: 
 silicone;    hydrophilic acrylic; and    hydrophobic acrylic.    
     
     
         3 . The intraocular lens of  claim 2 , wherein the material of the cantilevered arm and fixation members is selected from the group consisting of: 
 PMMA; and    polyether sulfone.    
     
     
         4 . The intraocular lens of  claim 1 , wherein the optic is a meniscus type of optic and has a center thickness of less than about 0.5 mm.  
     
     
         5 . The intraocular lens of  claim 1 , wherein the fixation members have a thickness and flexibility that enables them to be folded inward toward one another so as to overlap the optic and present a smaller insertion profile than the diameter of the optic.  
     
     
         6 . The intraocular lens of  claim 1 , wherein the cantilevered arm includes a main elongate portion and a paddle that overlaps one side of the flange, the intraocular lens further including: 
 a coupling member separate from the optic and cantilevered arm, the coupling member including a portion that overlaps the flange on the side opposite the paddle, and a stepped edge that has approximately the same thickness as the flange, the coupling member and paddle sandwiching the flange therebetween and the stepped edge of the coupling member directly contacting the cantilevered arm, wherein the cantilevered arm, flange, and coupling member define an attachment assembly, the assembly being bonded together.    
     
     
         7 . The intraocular lens of  claim 6 , wherein the assembly is bonded together using a method selected from the group consisting of: 
 heat staking;    laser welding; and    ultrasonic welding.    
     
     
         8 . The intraocular lens of  claim 1 , wherein the cantilevered arm and flange are attached together using a method selected from the group consisting of: 
 heat staking;    laser welding; and    ultrasonic welding.    
     
     
         9 . The intraocular lens of  claim 1 , wherein the flex portions of each fixation member extend generally away from one another adjacent to their respective proximal ends and then turn about 90 degrees to form substantial U-shapes that have lengths greater than the diameter of the optic, the U-shapes being oriented generally in parallel on diametrically-opposed sides of the optic.  
     
     
         10 . The intraocular lens of  claim 9 , wherein the lens is adapted for anterior chamber implantation and each flex portion of each fixation member includes a pair of spaced apart pods for contacting the iridio-corneal angle in the anterior chamber.  
     
     
         11 . The intraocular lens of  claim 10 , wherein each pair of pods is spaced apart at least seven mm.  
     
     
         12 . The intraocular lens of  claim 1 , wherein the lens is adapted for anterior chamber implantation and each flex portion of each fixation member includes a pair of spaced apart pods for contacting the iridio-corneal angle in the anterior chamber, wherein the four pods are arranged on the flex portions so that upon inward compression of between about 0.5-1.5 mm, they form a square in the iridio-corneal angle so as to reduce the chance of pupil ovalization.  
     
     
         13 . A foldable intraocular lens for implantation in the eye, the intraocular lens comprising: 
 an optic centered on an optical axis and made of a highly pliable material, the optic having a generally circular periphery;    a cantilevered arm extending radially outward from the optic periphery made of a material that is flexible but more rigid than the material of the optic, the arm being attached to the optic periphery using a method selected from the group consisting of: 
 heat staking;  
 laser welding; and  
 ultrasonic welding; and  
   a pair of fixation members integral with the cantilevered arm for supporting the optic centered on the optical axis of the eye, each fixation member having a proximal end at the outer end of the cantilevered arm, a distal end, and a flex portion intermediate the proximal and distal ends, the flex portions being oriented generally in parallel on diametrically-opposed sides of the optic.    
     
     
         14 . The intraocular lens of  claim 13 , wherein the fixation members have a thickness and flexibility that enables them to be folded inward toward one another so as to overlap the optic and present a smaller insertion profile than the diameter of the optic.  
     
     
         15 . The intraocular lens of  claim 13 , wherein the optic has an integral flange extending radially outward therefrom, and the cantilevered arm includes a main elongate portion and a paddle that overlaps one side of the flange, the intraocular lens further including: 
 a coupling member separate from the optic and cantilevered arm, the coupling member including a portion that overlaps the flange on the side opposite the paddle and a stepped edge that has approximately the same thickness as the flange, the coupling member and paddle sandwiching the flange therebetween and the stepped edge of the coupling member directly contacting the cantilevered arm, wherein the cantilevered arm, flange, and coupling member define an attachment assembly, the assembly being bonded together using the aformentioned methods.    
     
     
         16 . The intraocular lens of  claim 13 , wherein the flex portions of each fixation member extend generally away from one another adjacent to their respective proximal ends and then turn about 90 degrees to form substantial U-shapes that have lengths greater than the diameter of the optic, the U-shapes being oriented generally in parallel on diametrically-opposed sides of the optic.  
     
     
         17 . The intraocular lens of  claim 16 , wherein the lens is adapted for anterior chamber implantation and each flex portion of each fixation member includes a pair of spaced apart pods for contacting the iridio-corneal angle in the anterior chamber.  
     
     
         18 . The intraocular lens of  claim 17 , wherein each pair of pods is spaced apart at least seven mm.  
     
     
         19 . The intraocular lens of  claim 13 , wherein the lens is adapted for anterior chamber implantation and each flex portion of each fixation member includes a pair of spaced apart pods for contacting the iridio-corneal angle in the anterior chamber, wherein the four pods are arranged on the flex portions so that upon inward compression of between about 0.5-1.5 mm, they form a square in the iridio-corneal angle so as to reduce the chance of pupil ovalization.  
     
     
         20 . A foldable intraocular lens for implantation in the eye, the intraocular lens comprising: 
 an optic centered on an optical axis and made of a highly pliable material, the optic having a generally circular periphery and an integral flange extending radially outward therefrom;    a fixation member for supporting the optic centered on the optical axis of the eye, the fixation member having a proximal end, a distal end, and a flex portion intermediate the proximal and distal ends, the proximal end having an arm extending toward the optic and a paddle on the end thereof that overlaps the flange and is connected thereto; and    a coupling member separate from the optic and fixation member and including a portion that overlaps the flange, and a stepped edge that has approximately the same thickness as the flange, the coupling member and paddle sandwiching the flange therebetween and the stepped edge of the coupling member directly contacting the arm, wherein the arm, flange, and coupling member define an attachment assembly, the assembly being bonded together.    
     
     
         21 . The intraocular lens of  claim 20 , wherein the material of the optic is selected from the group consisting of: 
 silicone;    hydrophilic acrylic; and    hydrophobic acrylic.    
     
     
         22 . The intraocular lens of  claim 21 , wherein the fixation member, arm and paddle are integrally formed of a material that is flexible but more rigid than the material of the optic.  
     
     
         23 . The intraocular lens of  claim 22 , wherein the material of the arm and fixation members is selected from the group consisting of: 
 PMMA; and    polyether sulfone.    
     
     
         24 . The intraocular lens of  claim 20 , wherein the optic is a meniscus type of optic and has an edge thickness of less than about 0.5 mm.  
     
     
         25 . The intraocular lens of  claim 20 , wherein there are a pair of fixation members integral with the arm for supporting the optic centered on the optical axis of the eye, and wherein the flex portions are oriented generally in parallel on diametrically-opposed sides of the optic.  
     
     
         26 . The intraocular lens of  claim 25 , wherein the flex portions of each fixation member extend generally away from one another adjacent to their respective proximal ends and then turn about 90 degrees to form substantial U-shapes that have lengths greater than the diameter of the optic, the U-shapes being oriented generally in parallel on diametrically-opposed sides of the optic.  
     
     
         27 . The intraocular lens of  claim 20 , wherein the attachment assembly is bonded together using a method selected from the group consisting of: 
 heat staking;    laser welding; and    ultrasonic welding.    
     
     
         28 . The intraocular lens of  claim 20 , wherein the flange includes an aperture and coupling member has a projection that fits through the aperture and contacts the paddle on the other side of the flange.  
     
     
         29 . The intraocular lens of  claim 20 , wherein the fixation member arm and paddle and coupling member are made of the same material, and the attachment assembly is bonded together using heat such that the portions in direct contact fuse together.  
     
     
         30 . A method of folding and inserting an intraocular lens in an eye, comprising: 
 providing an intraocular lens having: 
 an optic centered on an optical axis and made of a highly pliable material, the optic having a generally circular periphery;  
 a cantilevered arm extending radially outward from the optic periphery made of a material that is flexible but more rigid than the material of the optic, the arm being bonded to the optic periphery; and  
 a pair of fixation members integral with the cantilevered arm for supporting the optic centered on the optical axis of the eye, each fixation member having a proximal end at the outer end of the cantilevered arm, a distal end, and a flex portion intermediate the proximal and distal ends, the flex portions being oriented generally in parallel on diametrically-opposed sides of the optic;  
   flexing both of the fixation members toward one another so that they overlap within the diameter of the optic and define an insertion profile of less than about 5 mm; and    passing the intraocular lens with the fixation members overlapping one another through an incision in the cornea of 5 mm or less without otherwise manipulating the optic into a fold.    
     
     
         31 . The method of  claim 30 , wherein the flex portions are oriented generally in parallel on diametrically-opposed sides of the optic, and the flex portions of each fixation member extend generally away from one another adjacent to their respective proximal ends and then turn about 90 degrees to form substantial U-shapes that have lengths greater than the diameter of the optic, the U-shapes being oriented generally in parallel on diametrically-opposed sides of the optic and having inner arms and outer arms, the method including flexing both of the fixation members toward one another so that the outer arms overlap the diameter of the optic.